Immune Response After Pancreatic Cancer Treatment (IRE Immuno)
25. februar 2020 oppdatert av: University Hospital Inselspital, Berne
Differential Immunologic Signature After Pancreatic Cancer Treatment: Does Irreversible Electroporation Lead to a Prolonged and Potent T-cell Mediated Immune Response Compared to Surgical Resection?
The aim of this project is to describe the differential immunologic responses of patients who undergo in situ IRE, margin accentuation IRE with surgical resection of the primary tumor, and surgical resection of the primary tumor only.
The primary hypothesis is that IRE induces a long and sustained activation of the cell-mediated immune system, which is distinct from the immune response after surgical resection only.
The primary endpoint of this study is the comparison of the CD4+/CD8+ ratio as an indicator of antitumor immunity both longitudinally within a group after the intervention and over time between the three groups.
CD4+/CD8+ ratio will be measured preoperatively and at postoperative days 1, 7, 42, and 180.
As a secondary outcome, additional measurements will be taken to more specifically characterize the immune response based on peripheral blood samples.
Flow cytometry will be used to quantify cell subsets, and ELISA will be used to measure cytokine levels , at the same time-points as for the primary outcome.
Each group of patients as described above will consist of 10 consecutive pancreatic cancer patients.
Patients aged 18 or older with resectable, borderline resectable, or locally advanced pancreatic cancer will be included.
Patients with locally advanced disease will undergo 3 months of preoperative chemotherapy with monitoring to exclude metastatic disease.
Main exclusion criteria are cardiac conduction abnormalities and signs of distant metastasis.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
38
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Bern, Sveits
- Inselhospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients undergoing an established procedure for pancreatic cancer.
The assignment into either group will be independent of this research proposal and rely completely on clinical judgment.
Main outcomes will be changes in immunological short-term and long-term outcomes.
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years
- Able to undergo general anesthesia (ASA ≤ 4)
- Performance status ECOG <=2 (Eastern Cooperative Oncology Group)
- Life expectancy of at least 6 months
- Resectable, borderline resectable, or locally advanced pancreatic cancer
- Patients who have locally advanced disease have to show no tumor progression after 3 month of neo-adjuvant chemotherapy+/-XRT before undergoing in situ IRE
Exclusion Criteria:
- Cardiac AV conduction abnormalities, ventricular fibrillation
- History of epilepsy
- Recent history of myocardial infarction (2 months)
- Evidence of distant metastasis (e.g. liver, lung, peritoneum)
- Informed consent cannot be given by the patient
- Known hypersensitivity to the IRE electrodes (stainless steel 304L)
- Women of childbearing potential who are pregnant, breast feeding, or not taking an adequate method of contraception at the time of procedure
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
10 IRE locally advanced
patients undergoing in situ IRE for locally advanced pancreatic
|
Irreversible electroporation is an emerging, mainly non-thermal ablative modality.
It circumvents some downsides of thermal ablation and has the potential for broad application among patients with pancreatic cancer.
|
|
10 IRE borderline resection
patients undergoing margin accentuation IRE for borderline resectable disease
|
Irreversible electroporation is an emerging, mainly non-thermal ablative modality.
It circumvents some downsides of thermal ablation and has the potential for broad application among patients with pancreatic cancer.
|
|
10 resection only
patients undergoing surgical resection only
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Immunological outcome
Tidsramme: 42 days
|
flowcytometry
|
42 days
|
|
Immunological outcome
Tidsramme: 6 months
|
Flowcytometry
|
6 months
|
|
Immunological outcome
Tidsramme: 9 months
|
Flowcytometry
|
9 months
|
|
Immunological outcome
Tidsramme: 42 days
|
ELISA
|
42 days
|
|
Immunological outcome
Tidsramme: 6 months
|
ELISA
|
6 months
|
|
Immunological outcome
Tidsramme: 9 months
|
ELISA
|
9 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of local tumor recurrences
Tidsramme: 42 days
|
measured via CT
|
42 days
|
|
Number of local tumor recurrences
Tidsramme: 3 months
|
measured via CT
|
3 months
|
|
Number of local tumor recurrences
Tidsramme: 6 months
|
measured via CT
|
6 months
|
|
Number of local tumor recurrences
Tidsramme: 9 months
|
measured via CT
|
9 months
|
|
Number of distant tumor recurrences
Tidsramme: 42 days
|
measured via CT
|
42 days
|
|
Number of distant tumor recurrences
Tidsramme: 3 months
|
measured via CT
|
3 months
|
|
Number of distant tumor recurrences
Tidsramme: 6 months
|
measured via CT
|
6 months
|
|
Number of distant tumor recurrences
Tidsramme: 9 months
|
measured via CT
|
9 months
|
|
Overall survival
Tidsramme: 42 days
|
survival of patient
|
42 days
|
|
Overall survival
Tidsramme: 3 months
|
survival of patient
|
3 months
|
|
Overall survival
Tidsramme: 6 months
|
survival of patient
|
6 months
|
|
Overall survival
Tidsramme: 9 months
|
survival of patient
|
9 months
|
|
Cancer specific survival
Tidsramme: 42 days
|
survival of patient
|
42 days
|
|
Cancer specific survival
Tidsramme: 3 months
|
survival of patient
|
3 months
|
|
Cancer specific survival
Tidsramme: 6 months
|
survival of patient
|
6 months
|
|
Cancer specific survival
Tidsramme: 9 months
|
survival of patient
|
9 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Mathias Worni, MD, Inselspital Berne
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. februar 2017
Primær fullføring (Faktiske)
25. februar 2020
Studiet fullført (Faktiske)
25. februar 2020
Datoer for studieregistrering
Først innsendt
20. desember 2016
Først innsendt som oppfylte QC-kriteriene
2. mars 2017
Først lagt ut (Faktiske)
3. mars 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. februar 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. februar 2020
Sist bekreftet
1. februar 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2016-02037
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